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Exploratory study of Transarterial Chemoembolization (TACE) combined with immunotherapy in the treatment of middle or advanced Stage hepatocellular Carcinoma(HCC)

Exploratory study of Transarterial Chemoembolization (TACE) combined with immunotherapy in the treatment of middle or advanced Stage hepatocellular Carcinoma(HCC)

Status
Active, not recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OPC-15006703
Enrollment
Unknown
Registered
2015-07-06
Start date
2016-12-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular carcinoma

Interventions

Sponsors

Gastrointestinal surgery,Fujian Provincial Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. With pathological diagnosis or diagnostic standards in line with the AASLD (the American association for the study of liver diseases) the prescribed standards for clinical diagnosis of Hepatocellular carcinoma; 2. A diagnosis of Hepatocellular carcinoma (not surgically removable), and accept the 2-3 cycles TACE therapy or postoperative recurrence of inoperable liver and accept 2-3 cycles TACE treatment; 3. BCLC tumour stage belongs to the mid-(B period), late (C phase); 4. liver function Child-Pugh score less than or equal to 7 points; 5. Easten Cooperative Oncology Group(ECOG) performance status 0-2; 6. Age >=18 years; 7. At least one measurable lesion by CT or MRI; 8. Life expectancy >=6 months; 9. Signed informed consent document; 10. Ability to comply with requirements of the protocol.

Exclusion criteria

Exclusion criteria: 1. Previous treatment with radiotherapy, chemotherapy, immunotherapy or targeted therapy; 2. History of organ allograft, autologous stem cell transplantation, or allogeneic stm cell transplantation; 3. Use of immunosuppressant within one month of trial entry, including corticosteroids >=1 months of continuous use those; 4. Previous exposure to any investigational treatment within 30 days before the first dose of study treatment; 5. Known and declared history of Acquired immunodeficiency syndrome (AIDS related diseases) or HIV infection need antiretroviral; 6. Other serious diseases, including epilepsy; 7. Pregnant or Lactating females; 8. Extrahepatic metastasis: There portal vein, inferior vena cava, hepatic vein tumor thrombus; abdominal lymph node metastasis; 9. Serious complications, such as uncontrolled hypertension, coronary heart disease, diabetes, heart failure, etc.; 10. Active infection; 11. A history of severe lung or heart disease; renal abnormalities, plasma creatinine exceeds 1.5 times the upper limit of normal; 12. Upper gastrointestinal bleeding had occurred caused by cirrhosis of the liver; 13. Legal incapacity or limited legal capacity; 14. Has a physical or mental illness, and by investigator believe can not be completely or fully understand the complications that may exist in this study; 15. History of other malignancy, other than curatively treated carcinoma in situ of the cervix, and curatively treated cutaneous basal cell carcinoma; 16. Any severe acute or chronic disease that make patient can't participate or impact the results of the study.

Design outcomes

Primary

MeasureTime frame
Progression-free surival;Safty of immunotherapy;Overall Survival;T/Treg cell;cytokines (IFN-beta, IL-10);

Countries

China

Contacts

Public ContactMinGang Ying
yingmg@163.com+86 13906906675

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026